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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE COROENT SYSTEM INTERVERTEBRAL BODY FUSION DEVICE

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NUVASIVE, INC. NUVASIVE COROENT SYSTEM INTERVERTEBRAL BODY FUSION DEVICE Back to Search Results
Model Number 5485555
Device Problem Loss of Osseointegration (2408)
Patient Problem Failure of Implant (1924)
Event Date 01/21/2011
Event Type  Malfunction  
Event Description

A lateral interbody implant containing 2 interfixated bone screws was inserted in the l4-l5 disc space on (b)(6) 2010. There was no supplemental fixation added posteriorly at that time. 4-month post-op plain film dated (b)(6) 2011 showed the l5 (inferior) screw had begun backing out of the interbody implant and a moderate amount of implant subsidence was also noted. 6 month follow-up films on (b)(6) 2011 showed additional screw backout and interbody subsidence. On (b)(6) 2014 the pt presented with right groin pain, at which point plain film depicted the inferior screw had further backed out of the interbody device. Revision surgery was performed on (b)(6) 2014, during which the screw was removed and unilateral pedicle screws were added. The removed lateral screw was discarded by the user facility.

 
Manufacturer Narrative

(b)(4). Per the surgeon, the pt has reported a complete resolution of pain and lower extremity weakness post-revision surgery. No permanent impairment or injury occurred. The device was discarded by the hosp and has not been returned for failure investigation. No additional eval has been possible. No supplemental fixation was added during the initial surgery in (b)(6) 2010. This lateral interbody device is not intended to be used for standalone spinal fixation. See scanned page.

 
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Brand NameNUVASIVE COROENT SYSTEM
Type of DeviceINTERVERTEBRAL BODY FUSION DEVICE
Manufacturer (Section D)
NUVASIVE, INC.
san diego CA
Manufacturer Contact
brett greenwald
7475 lusk blvd
san diego, CA 92121
8583205252
MDR Report Key4095067
MDR Text Key19298856
Report Number2031966-2014-00051
Device Sequence Number1
Product Code MAX
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK071795
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/30/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/30/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number5485555
Device LOT NumberNOT AVAILABLE
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/09/2014
Event Location Home
Date Manufacturer Received07/01/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/30/2014 Patient Sequence Number: 1
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